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Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

NCT02738203 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-06-06

Study results available
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Summary

For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.

Conditions

  • IUD Insertion

Interventions

DRUG

Vaginal 2% Lidocaine

Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly

DRUG

Surgical Lubricant Jelly

Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly

Sponsors & Collaborators

Principal Investigators

  • Jennifer A Conti, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-10-19
Completion
2017-10-19

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02738203 on ClinicalTrials.gov